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New Veterinary Medicinal Products Act “TAMG”
Since January 28, 2022, the EU Veterinary Medicinal Products Regulation 2019/6, various legal acts and the new Veterinary Medicinal Products Act “TAMG” apply. The regulations for handling veterinary medicinal products differ in part considerably from the previous regulations of the “Medicinal Products Act” / oder German Drugs Act AMG. In the Medicines Act (AMG), which previously applied to both areas, the provisions relating to veterinary medicines will be repealed at the same time.
- Purchase of veterinary medicinal products by animal owners
- Use of (veterinary) medicinal products by the animal keeper
- Proof of use by the animal keeper
- Use and purchase of medicinal products by the veterinary practitioner
It is necessary to deal with the new pharmaceutical regulations. These are very extensive overall. Therefore, this article deals specifically with the regulations concerning the independent use of medicinal products by animal owners (e.g. farmers) or other persons (e.g. veterinary practitioners) with veterinary medicinal products subject to pharmacy prescription in food-producing animals and in small animals, i.e. in short: What may the farmer use independently or what may the veterinary practitioner use?
Purchase of veterinary medicinal products by animal owners
The TAMG states in “§ 49 Purchase of medicinal products and veterinary technical products” in ten paragraphs who can purchase veterinary medicinal products and under which conditions. Paragraph seven is important for animal owners:
(7) An animal owner may solely purchase pharmacy-only veterinary medicinal products and veterinary technical products from pharmacies or from a veterinarian treating the animal as part of the operation of a veterinary home pharmacy.
Thus, it is clarified that, for example, farmers can also purchase pharmacy-only veterinary medicinal products from a pharmacy. Another important point is:
(8) Persons other than those specified in paragraphs (1) through (7) may purchase pharmacy-only veterinary drugs and veterinary technical products solely from pharmacies.
Thus, it is clarified that other persons, e.g., veterinary practitioners may/must purchase veterinary medicinal products subject to pharmacy only in a pharmacy.
Use of (animal) medicines by the animal owner
The “EU Veterinary Medicinal Products Regulation 2019/6 Section 3, Application, Article 106 Sentence 1” specifies the new TAMG in “Section 50 Application of Veterinary Medicinal Products” the topic. Sentence 4 is particularly important for farmers:
(4) Pharmacy-only veterinary medicinal products and veterinary technical products whose use is not based on a veterinary treatment order may only be used on animals,
1. if the veterinary medicinal products and veterinary technical products are authorized or registered,
2. for the animal species designated in the labeling or package insert,
3. if the veterinary medicinal products are authorized, for the indications specified in the labeling or package insert and
4. in a quantity which, according to the dosage and the duration of application, corresponds to the labeling or package insert of the respective veterinary drug.
This clearly describes that farmers, as before, are allowed to use pharmacy-only veterinary medicines independently, i.e. without a veterinary prescription, according to the instructions in the package insert. But solely pharmacy-only veterinary medicines, no human medicines.
Specifically, globules from the human sector were and are prohibited for food-producing animals.
With the entry into force of the new EU Veterinary Medicinal Products Regulation 2019/6 and the new TAMG, the possibilities of a “redesignation” by veterinarians will also be limited and complicated. It should also be noted that veterinary medicinal products that are approved or registered “for animals” in other EU member states are not automatically
marketable in Germany. The drug must always be registered or approved in Germany and for the corresponding animal species. Consequently, a thorough examination is necessary before use, even when purchased from a foreign pharmacy.
Evidence of application by the animal keeper
In this regard, the EU Regulation 2019/6 Article 108 states: “Record keeping by owners and keepers of food-producing animals”.
Paragraphs 1-3 are particularly important for animal owners:
(1) The owners or – if the animals are not kept by the owners – the keepers of food-producing animals shall keep records of the medicinal products they use and, if necessary, keep a copy of the veterinary prescriptions.
(2) The records referred to in paragraph (1) shall include:
(a) The date the drug was first administered to the animals,
(b) name of the medicinal product,
(c) Quantity of the drug administered,
(d) name or business name and permanent address or registered office of the supplier,
(e) proof of purchase of the medicinal product applied,
(f) identity of the animal or group of animals treated,
(g) name and contact information of the prescribing veterinarian, if applicable.
(h) Waiting period, even if this period is zero,
(i) duration of treatment.
3. Where the information to be recorded in accordance with paragraph 2 of this Article is already contained in the copy of a veterinary prescription, in the records kept on the farm or, in the case of equidae, in the single identification document valid for life referred to in Article 8 (4), it need not be recorded separately.
This clarifies the extent to which the use of veterinary medicinal products must be documented.
Use and purchase of medicines by veterinary practitioners
In the “EU-VO 2019/6” and the new “TAMG” veterinary practitioners, or persons practicing veterinary medicine, are not directly mentioned. Thus, the legal regulations apply to “other persons”. This means that this group of persons, simply put, is only allowed to work (treat) with over-the-counter or pharmacy-only veterinary medicinal products or veterinary medicinal products, according to the descriptions in the technical information and instructions for use. Veterinary and human medicinal products can also not be redesignated by veterinary practitioners.
Summary
The application of the EU Veterinary Medicinal Products Regulation 2019/6, various legal acts and the new Veterinary Medicinal Products Act “TAMG” is now applicable. There are many changes, but also clarifications. The independent therapy by farmers with pharmacy-only and over-the-counter veterinary medicinal products is fixed and remains.
Important note
From the extensive texts of regulations and laws, only a few provisions could and should be discussed here. This information does not claim to be complete. Although the greatest possible care has been taken in compiling the information, no liability can be accepted for the correctness of the content. Only the experience
gained afterentering into force will show the strengths and weaknesses of the new regulations.
Author: Franz Ziegler; Picture credits: Countrypixel stock.adobe.com, floop-istockphoto.com
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